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Swiss Primary Sclerosing Cholangitis Cohort Study

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ClinicalTrials.gov Identifier: NCT03146936
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Fondazione Epatocentro Ticino

Brief Summary:

Research project in which biological material is sampled and health-related personal data is further used and collected.

Coded data are used.


Condition or disease
Cholangitis, Sclerosing

Detailed Description:
The investigators wish to collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, a biobank allows addressing specific scientific issues on a variety of open questions. The cohort will provide a platform for carrying out scientific research projects on PSC. In addition, the cohort will allow collaborations with reference networks on PSC abroad

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Swiss Primary Sclerosing Cholangitis Cohort Study
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022





Primary Outcome Measures :
  1. Disease course [ Time Frame: 3 years ]
    Observing disease course

  2. Disease features [ Time Frame: 3 years ]
    Observing disease features in Swiss population and see if they are similar to other countries'

  3. Response to treatment [ Time Frame: 3 years ]
    Observing response to treatment

  4. Overall survival [ Time Frame: 3 years ]
    Observing overall survival

  5. Transplantation-free survival rate [ Time Frame: 3 years ]
    Observing transplantation-free survival rate


Biospecimen Retention:   Samples With DNA
  1. Serum (BD Vacutainer® SST II Advance)
  2. RNA (PAXgene™ Blood RNA tube- 762165)


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
PSC patients living in Switzerland of any age Patients diagnosed with PSC according to established criteria (European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases). Only patients living in Switzerland are enrolled. Enrollment of minors is possible upon consent of legal guardian
Criteria

Inclusion Criteria:

  • Patients diagnosed with PSC according to established criteria (European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases) of any age. Patients not fulfilling such criteria but still diagnosed with PSC in a hepatology referral centre can be included
  • patients living in Switzerland

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146936


Contacts
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Contact: Benedetta Terziroli Beretta-Piccoli, MD +41919608503 benedetta.terziroli@hin.ch
Contact: Benedetta Terziroli Beretta-Piccoli, MD Terziroli Beretta-Piccoli benedetta.terziroli@hin.ch

Locations
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Switzerland
Fondazione Epatocentro Ticino Recruiting
Lugano, Ticino, Switzerland, 6900
Contact: Benedetta Terziroli Beretta-Piccoli, MD    +41919608507    benedetta.terziroli@hin.ch   
Universitäts-Kinderspital beider Basel UKBB, Gastroenterologie&Ernährung Recruiting
Basel, Switzerland, 4031
Contact: Raoul Furlano, PD MD    +4161 704 12 13    raoul.furlano@ukbb.ch   
Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Maria Gabriela Delgado, MD    +4131 632 09 00    mariagabriela.delgado@insel.ch   
Kinderklinik, INSELSpital, Universität Bern, Pädiatrische Gastroenterologie, Hepatologie und Ernährung Recruiting
Bern, Switzerland, 3010
Contact: Christiane Sokollik, MD    +4131 632 50 93    Christiane.Sokollik@insel.ch   
Kantonsspital Graubünden, Departement für Kinder- und Jugendmedizin Recruiting
Chur, Switzerland, 7000
Contact: Matthias Cremer, MD    +4181 256 6098    Matthias.Cremer@ksgr.ch   
Hôpitaux Universitaires de Genève, Centre Suisse des Maladies du foie de l'Enfant- Département de l'Enfant et de l'Adolescent Recruiting
Geneve, Switzerland, 1205
Contact: Valérie McLin, Prof.    +4122 382 45 72    Valerie.Mclin@hcug.ch   
Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités Recruiting
Geneve, Switzerland, 1205
Contact: Nicolas Goossens, MD    +4122 372 93 55    Nicolas.Goossens@hcuge.ch   
CHUV Département femme-mère-enfant Recruiting
Lausanne, Switzerland, 1011
Contact: Andreas Nydegger, MD    +41 21 314 11 11    andreas.nydegger@chuv.ch   
Kantonsspital Baselland Recruiting
Liestal, Switzerland, 4410
Contact: Magdalena Filipowicz-Sinnreich, MD    +41 61 925 23 60    Magdalena.Filipowicz@ksbl.ch   
Kinderspital Luzern LUKS, Pädiatrische Gastroenterologie Recruiting
Lucerne, Switzerland, 6000
Contact: Johannes Spalinger, MD    +4141 205 32 09    johannes.spalinger@luks.ch   
Ostschweizer Kinderspital Recruiting
Sankt Gallen, Switzerland, 9006
Contact: Pascal Müller, MD    +4171 243 13 44    pascal.mueller@kispisg.ch   
Kantonsspital St.Gallen Recruiting
Sankt Gallen, Switzerland, 9007
Contact: David Semela, MD    +4171 4941216    David.Semela@kssg.ch   
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, 8400
Contact: Björn Becker, MD    +41 052 266 21 21    bjoern.becker@ksw.ch   
Universitäts-Kinderspital Zürich - Eleonorenstiftung Recruiting
Zurich, Switzerland, 8032
Contact: Christian P. Braegger, Prof.    +41 44 266 84 62    christian.braegger@kispi.uzh.ch   
Universitätsspital Zürich Recruiting
Zurich, Switzerland, 8091
Contact: Joachim Mertens, MD    +41 44 255 11 11    Joachim.mertens@usz.ch   
Sponsors and Collaborators
Fondazione Epatocentro Ticino

Additional Information:

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Responsible Party: Fondazione Epatocentro Ticino
ClinicalTrials.gov Identifier: NCT03146936     History of Changes
Other Study ID Numbers: SASL40 - Swiss PSC Cohort
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases